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中成药大洗牌 天然药物“桑枝总生物碱片” 以化药级标准提供转型范本
Sou Hu Wang· 2026-02-04 07:53
Core Viewpoint - The recent news about a large number of traditional Chinese medicines being withdrawn from the market is due to new regulations from the National Medical Products Administration, which will impact over 70% of existing traditional Chinese medicine approvals by 2026 [1][2]. Group 1: Regulatory Changes - The National Medical Products Administration issued the "Special Regulations on the Registration of Traditional Chinese Medicines" in February 2023, which states that any unclear safety information in the drug registration application will lead to non-renewal after three years [1]. - As of July 1, 2023, this regulation has been in effect, leading to significant concerns in the industry regarding the future of traditional Chinese medicines lacking clinical data and clear safety descriptions [1]. Group 2: Product Highlight - The product "Sangzhi Total Alkaloid Tablets," approved under the Z category, stands out as a benchmark for innovation in traditional Chinese medicine, demonstrating strong clinical efficacy and clear indications [1][2]. - This product is based on 21 years of research by a team led by Professor Liu Yuling from the Chinese Academy of Medical Sciences and has received significant national project support [2]. Group 3: Clinical Evidence - Sangzhi Total Alkaloid Tablets underwent a head-to-head clinical trial against first-line chemical drugs, showing a reduction in glycated hemoglobin by 0.93% and superior postprandial blood glucose control compared to the chemical drug Baidu [2]. - The clinical trial results were published in the prestigious journal "Diabetes Care," providing high-level evidence for the efficacy of this traditional medicine [2]. Group 4: Industry Impact - The product's clear labeling of indications, adverse reactions, and precautions based on clinical data sets a new standard for traditional Chinese medicine, aligning with the new regulatory requirements [3]. - As the industry faces a significant transformation, Sangzhi Total Alkaloid Tablets exemplify a successful model of integrating traditional and modern medicine, emphasizing efficacy and safety [9].